Evaluate Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs

Neuroendocrine Tumors Clinical Trial

— MACS2002  

Official title:

Extension Study to the "Open-label Phase I Study Evaluating the Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs - The COOPERATE-1 Study"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01590199
• Other study ID #: CRAD001KDE47
• Status: Completed
• Phase: Phase 1
• Start date: May 18, 2012
• Est. completion date: September 11, 2018

Study information

• Verified date: April 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate long-term safety and tolerability of pasireotide LAR in combination with everolimus in advanced metastatic NET patients, who who have not progressed during 12 months of combination therapy with pasireotide LAR and everolimus

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 11, 2018
• Est. primary completion date: September 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion and Exclusion Criteria:

Patients eligible for inclusion in this extension study have to meet all of the additional inclusion criteria:

• The patient must provide a signed Informed Consent Form (ICF) for the extension study prior to any study related procedures

• Completion of the whole treatment period of 15 months (3 months monotherapy with either pasireotide LAR or everolimus followed by a 12 months combination of pasireotide LAR/everolimus) in the CSOM230F2102 study

• No tumor progression during 12 months of combination therapy with pasireotide LAR and everolimus (checked via radiologically assessment).

No intolerable toxicity during combination therapy with pasireotide LAR and everolimus

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

Drug:
• RAD001

• SOM230

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Bad Berka
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Muenster

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events and Serious Adverse Enents as a Measure of Safety and Tolerability		up to 4 years
Primary	Number of Participants with abnormal laboratory and ECG results as a Measure of Safety and Tolerability		up to 4 years
Secondary	investigator-assessed progression free survival (PFS)		up to 4 years
Secondary	best overall response		up to 4 years